510(k) K981681 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)
| Applicant | Gambro Healthcare, Lakewood CO, US |
| Decision | Substantially Equivalent, Aug 11, 1998 |
| Received | May 13, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981681
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 5, 2006 | Gambro Renal Products, Inc. Gambro Prisma M100 preset, Part No. 8353486. Terminated |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.